Requirements for processing (rendering) plants
Contents
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What is rendering?
Where do I find the Standard Processing Methods?
How do I become approved?
Do I need to carry out validation?
What are the specific requirements for method 7 processing?
Separation: why is it important?
What are the separation requirements at processing plants?
What additional hygiene requirements are required?
What operational requirements need to be met?
What are the specific requirements for category 1 and 2 materials?
What are the specific requirements for category 3 materials?
What are the specific separation requirements for rendering plants on the same site as
slaughter houses?
How should waste water be treated?
What routine microbiological testing is needed?
Do I need a Standard Operating Procedure?
What are the requirements regarding permanent marking with glyceroltrihepatanoate
(GTH)?
What is rendering?
Rendering is a process which involves cooking animal by-products at high temperature,
sometimes under pressure, allowing water to be removed and tallow to be separated from the
proteinaceous material.
Where do I find the Standard Processing Methods?
The relevant EU legislation is:
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Regulation 1069/2009 hereafter referred to as the “Control Regulation”.
Implementing Regulation 142/2011 hereafter referred to as the “Implementing
Regulation”.
Annex IV chapter III of the EU Implementing Regulation provides detail of the seven standard
processing methods including times, temperatures and particle size requirements. The method
of processing required will depend on the category and nature of the raw material being
processed.
How do I become approved?
Applications are available on the DARD website or can be completed online via this link. You
can also obtain an application form by contacting Veterinary Service on 028 905 25275 or
applications.aiabp@dardni.gov.uk.
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This form must be completed and returned to allow an approval inspection to be arranged.
Detailed conditions will need to be complied with and you will need to satisfy the inspecting
officer that you are able to operate the facility in compliance with the legislation. If satisfied,
DARD Veterinary Service will issue an approval document that will allow you to operate.
Once approved you will be subject to routine inspections, the frequency of which will be based
on the risk posed by the operation and how compliant you are in its operation. Currently there
are no charges for these approval or routine inspections.
Do I need to carry out validation?
As part of the approval process, the operator must carry out a validation of the process. The
purpose of validation is to define the operational parameters of a given process which will
achieve the requirements set out in the legislation. It is the responsibility of the operator to carry
out this validation but it should be carried out in discussion with the DARD Veterinary Officer
(VO). The validation requirements are described in Annex XVI chapter I section 2 of the EU
Implementing Regulations.
Validation only needs to be repeated following a significant change in the process, for example,
changes of raw materials, where a change in throughput rate has occurred or where a change
in processing machinery has taken place. If a significant change has occurred and the operator
has successfully revalidated the new process with the DARD VO prior to any change.
Method 7 processing may require specific microbiological requirements to be met prior to
approval (see below: ‘What are the specific requirements for method 7 processing?’).
What are the specific requirements for method 7 processing?
The EU Implementing Regulation sets out the criteria for authorisation of method 7 processing.
Any processing method can be authorised by the competent authority as processing method 7
where the following have been demonstrated by the operator to that authority:
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the identification of relevant hazards in the starting material, in view of the origin of the
material, and of the potential risks in view of the animal health status of the Member
State or the area or zone where the method is to be used
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the capacity of the processing method to reduce those hazards to a level which does not
pose any significant risks to public and animal health
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the sampling of the final product on a daily basis over a period of 30 production days in
compliance with the following microbiological standards:
Samples of material taken directly after the treatment:
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Clostridium perfringens absent in 1g
Samples of material taken during or upon withdrawal from storage:
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Salmonella absent in 25g: n=5, c=0, m=0, M=0
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Enterobacteriaceae: n=5, c=2; m=10; M=300 in 1 g
The above parameters are explained in the guidance laboratory requirements for animal byproduct testing
All of the final product must either be retained until the end of the 30 day testing period or be
disposed. Disposal must be by a route approved for the disposal of that category of raw animal
by-product.
If any of the 30 day test results fail to meet the Salmonella microbiological standards then
action, under the control of an officer of DARD, will be taken under the Zoonosis Order. This
will involve reprocessing of destruction of the final product. Similar action will be taken in
respect of other failures.
The competent authority may authorise any processing method as method 7 if the following
have been demonstrated/provided by the operator to that authority:
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full description of process: including details of how the process will operate and a
process flow diagram; defined critical control points (temperature, pressure, exposure
time, pH, particle size); equipment specification including calibration details HACCP plan
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full description of raw material: category, sub-category, physical properties (particle size,
water content); Pre-treatment (if any)
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identification of biological hazards (human and animal health). These hazards should be
identified in view of origin of the raw material, category, sub-category, the animal health
status of the Member State or area or zone where method is used and the
destination/use of the product
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demonstration of risk reduction: demonstrate the capacity of the method to reduce the
identified hazards to a level which does not pose significant risks to public and animal
health. This should be done by focusing on the relevant hazard that is most difficult to
inactivate
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the mechanism for demonstrating risk reduction will be dependent on the process and
the nature of the risk. The onus is on the process operator to demonstrate that risks have
been reduced.
This can be achieved by one of the following approaches:
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Demonstrate quantitatively the reduction of endogenous indicator organisms that are
consistently present in the raw material in high numbers. This can be achieved by testing
the raw material in order to identify what organisms are present, followed by testing the
finished product to demonstrate adequate reduction in the number of those organisms.
These organisms must not be less resistant to the treatment process than other identified
biological hazard present in the raw material
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Established risk reduction. Where factors leading to the reduction of risk are well known
(documented), the model of risk reduction is well established and continuous direct
measurement of the factors leading to risk reduction are in place then this can be used to
confirm the treatment would result in risk reduction
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Experimental validation: Introduction of a well-characterised test organism, in a suitable
test body, into the starting material and subsequent testing of the final product to confirm
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risk reduction (this approach should always be discussed with Veterinary Service prior to
carrying out any such validation exercise).
Approvals for method 7 processing issued prior to the 4th March 2011 under regulation
EC/1774/2002 will generally be accepted, unless it is considered that the microbiological
hazards had not previously been identified. The approval of processing method 7 issued before
and after 4th March 2011 may be suspended (permanently or temporarily) by the competent
authority (DARD) if there is evidence that the relevant microbiological hazards in the starting
material or the capacity of the method to reduce the hazards to acceptable health levels, for
animal and public, have changed substantially.
Separation: why is it important?
Separation of materials is vital to ensure the risks associated with animal by-products are
effectively controlled. This includes keeping raw feedstocks separate from the processed final
product and also separation of categories of by-products. For more information see our
Categorisation of animal by-products page.
In order to prevent cross contamination, different categories of animal by-products should
ideally be rendered on separate sites. However, this is not always practical and some
processing plants will wish to render more than one category of product on the same site. In
these cases it is essential separation is maintained between categories of unprocessed animal
by-products and also between the unprocessed and the processed products.
Within each category, separation between lines processing different species may also be
required. Currently, the outputs of mammalian, fish and poultry lines may all have different uses
if they are guaranteed free of cross-contamination.
What are the separation requirements at processing plants?
Procedures must be in place, and followed to ensure different categories of animal by-products
are kept separate from each other at all times. To minimise the risk of cross-contamination,
adequate physical separation is needed. This can be broken down into specific areas:
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Design and Structure
Buildings
Equipment
Cleaning and Disinfection
Storage
Personnel
Design and Structure
The plant must be designed to provide a clearly defined ‘unclean’ sector where raw material is
received and a ‘clean’ sector where finished product is dispatched. The operation of the plant
should be structured to ensure a one-way flow of material from receipt of raw material through
the processing stage and on to storage of the final product with no opportunity for by-pass.
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Buildings
The reception bay must be covered and constructed in such a way to allow easy cleansing and
disinfection.
Concrete or other durable floor surfaces must be in good condition and layed to facilitate the
drainage of liquids. Floors with proper falls will help washing water and effluent to drain. Walls
should be similarly constructed of durable material. Breezeblock is porous and must be sealed
either by rendering or the use of other durable coverings e.g. certain paints.
Equipment
Equipment must be dedicated to a single category of animal by-product, ideally this will involve
identifying equipment e.g. colour coding.
Equipment movement should be restricted, for example, if the process requires the size of
animal by-products to be reduced prior to processing, then the equipment used to do this should
be situated and remain in the unprocessed, ‘unclean’ sector.
If it is necessary to use equipment for a different category then full cleaning and disinfection
procedures must be followed (if transferring equipment used for category 1 processing to
category 2 or 3 processing then this will require caustic decontamination). Similarly, if it is
necessary to move equipment from the unclean to the clean sector then it must undergo full
cleaning & disinfection.
Maintenance work should only be carried out by trained and competent staff. They must ensure
their routine work does not result in different categories of animal by-products contaminating
each other. Procedures for maintaining and service of equipment should be included in the
Standard Operating Procedure (SOP) for the plant.
Cleaning and Disinfection
Facilities must be available for cleaning and disinfecting the containers in which animal byproducts are received and the vehicles in which they are stored or transported. The type of
facilities will depend on the situation for example steam cleaner, hand-held hose or automated
cleaning system or chemical disinfection using an approved disinfectant. Facilities must be
available to allow for the disinfection of vehicle wheels and other parts of the vehicle when they
leave the unclean sectors of site. Splashes or run-off from the cleaning areas must not
contaminate the processed product.
Storage
Different categories of unprocessed animal by-products must be stored separately unless they
are to be mixed and rendered as the higher risk category. Products from separate lines must be
stored separately unless destined for the same disposal route. If processed products derived
from different categories or different species are stored together then all of the stored products
must be treated as being of the higher risk material.
Personnel
Procedures must be put in place to control the movement of personnel between areas, including
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disinfection of footwear and changing protective clothing to prevent by-pass of material. Colour
coded protective clothing should be used to ensure separation between personnel working in
clean and unclean areas. Procedures must also be in place to control by-pass risks in
communally used areas such as lavatories, changing rooms and canteens.
All staff working on the premises must be adequately trained for their job(s). The training must
include awareness of the SOP and any critical control points within their area of responsibility. A
written record of such training should be maintained. It is also recommended that a list of
personnel who own livestock is maintained for notifiable disease contingency planning
purposes.
What additional hygiene requirements are required?
In addition to the details given above, the following general hygiene requirements are needed
for rendering plant approvals:
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Cleaning procedures must be established for all areas of the rendering plant. Regular
hygiene inspections of the environment and equipment must be carried out and
documented to ensure the cleaning procedures are being followed. Splashes or run-off
from the cleaning must not be allowed to come into contact with the final processed
product
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Adequate lavatories, changing rooms and washbasins must be provided for staff. These
facilities should either be part of the work area or immediately adjacent to it. Portable
lavatories are acceptable; however facilities located in dwelling houses are not
acceptable
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The rendering plant must have a waste-water disposal system (see below ‘How should
waste water be treated’)
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The plant must have appropriate arrangements for protection against pests, such as
insects, rodents and birds. As far as practicable the premises must be insect, bird and
rodent proof, and there should be a rodent control programme. The operator should also
take measures to minimise the level of insects in the premises using screens and/or
insect control measures e.g. electrical insect killer.
What operational requirements need to be met?
The rendering plant must have control over the operation of the plant in order to ensure
separation of materials is achieved, processing conditions are met and all documentation is in
place. Equipment must be checked regularly and kept in a good state of repair.
Where heat or pressure treatment is required, all installations must be equipped with continuous
measuring equipment to monitor temperature and, where applicable, pressure at critical points.
Measuring equipment i.e. pressure gauges thermocouples and recorders, must be calibrated at
least once a year and records of calibration kept.
Any material that has not received the specified heat treatment must be re-circulated through
the heat treatment, reprocessed or disposed of in accordance with the ABP Regulations.
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If categories of Animal by-products are mixes then the whole consignment will be regarded as
the higher risk, for example, if category 1 material is mixed with category 2 material, then the
whole consignment should be considered as category 1.
The processing plant must have sufficient production capacity for hot water and steam for the
processing of ABPs.
What are the specific requirements for category 1 and 2 materials?
If a rendering plant wishes to process both category 1 and 2 material on a single site the ABP
regulation requires total separation of the category 1 material from the category 2 material
throughout the whole process i.e. from reception of the raw material through to the dispatch of
the final product. Total separation should be taken to mean that the two processing lines
operate in separate parts of the building i.e. divided by a wall or partition. Areas with exposed
raw and processed material must be completely separated by floor to ceiling wall or partitions.
Note: if categories of Animal by-products are mixed then the whole consignment will be
regarded as the higher risk and will require processing as such.
What are the specific requirements for category 3 materials?
Plants processing category 3 materials cannot be located on the same site as plants processing
category 1 or 2 animal by-products, unless they are located in completely separate buildings i.e.
divided by a wall or partition. Areas with exposed raw and processed material must be
completely separated by floor to ceiling wall or partitions.
Approval may be given to handle and process category 3 material on the same site as category
1 and 2 if the following measures are put in place to avoid cross-contamination:
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the layout and management of the premises, in particular the reception area, process
lines including equipment, and storage of products must ensure separation of materials
and prevent cross contamination
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appropriate procedures for cleaning and disinfection must be in place and enforced,
taking into account the increased level of risk.
If the category 3 rendering plant is producing products that are destined to be fed to animals
then they must have mechanisms in place to detect and remove foreign bodies such as packing
material, plastic or metallic items from either the raw material or the finished product. Such
foreign bodies must be removed before or during processing.
What are the specific separation requirements for rendering plants on the same site as
slaughter houses?
Animal by-product rendering plants cannot be located on the same site as slaughterhouses or
other establishments approved or registered in accordance with Regulation (EC) No 852/2004
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or Regulation (EC) No 853/2004 unless controls are put in place to mitigate the risk to public
and animal health resulting from rendering animal by-products which originate from
slaughterhouses or other establishments. As a minimum requirement these measures must
include:
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the plant must be physically separate from the slaughterhouse or other establishment i.e.
in a completely separate building
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a conveyer system must be used to link the slaughterhouse or other establishment to the
rendering plant. This must not be by-passed
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both establishments must have separate entrances, reception bays, equipment and exits
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routine operation of staff on the two sites should be separate i.e. no shared facilities
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unauthorised persons and animals must not have access to the rendering plant.
How should waste water be treated?
All processing plants must have a waste-water disposal system meeting the requirements set
out by the competent authority in accordance with EU legislation.
Category 1 and category 2 rendering plants are required to have waste water pre-treatment
system in place consisting of drain traps or screens with a mesh size of no more than 6mm in
the downstream end of the process. The purpose of this system is to ensure that any solid
material in the waste water is less than 6mm in size. Only waste water that has been filtered
through the pre-treatment system can leave the premises.
It is not permitted to grind, macerate or pre-process solid material to allow it to pass through the
pre-treatment system.
Any material captured in the pre-treatment system must be collected and disposed of as
category 1 or category 2 material according to the ABP Regulations.
It is not permissible to dispose of liquid animal by-products (e.g. blood or milk) or derived
products through the waste water system even if it passes through the pre-treatment system.
What routine microbiological testing is needed?
Operators are required to carry out microbiological testing on finished products. The nature and
frequency of testing depends on the source of the raw material and the intended final
destination of the processed material.
For validation purposes:
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methods 1 to 6 do not require bacteriology testing, however, method 7 processing does
require Clostridium, Salmonella and Enterobacteriacaea testing (see ‘What are the
specific requirements for method 7 processing?’).
For routine sampling purposes:
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final product derived from Category 1 material which is going for destruction or to landfill
and final product derived from Category 2 material which is going for destruction or to
landfill does not require testing
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final product derived from Category 2 and Category 3 material which is going to be used
as OF/SI, biogas or composting must be sampled for Salmonella and Enterobacteriacea
weekly
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final product derived from Category 3 material, which is destined for use in feeding stuffs
must be sampled every day that material is consigned from the premises. The samples
must be tested for Salmonella and Enterobacteriacea
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final product derived from Category 3 material, which is not intended for use in feeding
stuffs must be sampled for Salmonella and Enterobacteriacea weekly unless it is going
for destruction or to land fill in which case no testing is required.
The plant must have its own laboratory on site or make use of an external laboratory that is
equipped to carry out the necessary testing. The laboratory must be accredited to international
standard ISO17025 in order to carry out testing. Guidance on laboratory requirements for ABP
is available here.
Do I need a Standard Operating Procedure?
In addition to a detailed Hazard Analysis and Critical Control Points (HACCP) plan which details
the control of the processes within the plant, a standard operating procedure (SOP) is also
required. While these are often held as a single document it is essential that the HACCP plan is
clearly identified and accompanied by monitoring and corrective action documentation.
As a minimum, the SOP should include the following information:
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management of common and shared areas including the procedures to be followed if
cross-contamination occurs:
o
Common areas will include canteens, offices, waste water treatment plants and
boilers. Procedures to avoid cross-contamination in common areas could include
a requirement for ‘staff must remove their outer clothing and change their footwear
before going to the common area’
o
Shared areas include those where animal by-products are handled or transported.
For Category 1 and 2 lines, shared areas may include raw material intake and
storage within the same airspace; two or more cookers in the same airspace;
weighbridge; entrances from the public highway; lorry parking and washing.
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management of spillages of any animal by-products and/or processed products
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equipment management including mobile equipment (e.g. colour coding), procedures for
dealing with breakdowns, maintenance, etc
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personnel requirements including training
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storage requirements for raw materials and final products.
What are the requirements regarding permanent marking with glyceroltrihepatanoate
(GTH)?
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Annex VIII chapter V of the EU Implementing Regulation lays down the specific requirements
for permanently marking category 1 or category 2 derived products with glyceroltrihepatanoate
(GTH).
GTH is a fat that does not occur in nature and that can withstand the extreme sterilisation
conditions used in rendering plants. When applied to a rendering process, GTH concentrates in
the processed fat or in the fat component of meat & bonemeal and can be used to permanently
mark the final product. This will allow processed category 1 and 2 materials to be identified post
rendering.
There are currently two laboratories in the UK that can carry out tests to detect GTH:
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Laboratory of the Government Chemists
Agri-Food Biosciences Institute.
There is no requirement to incorporate GTH into processed animal by-products that are
destined for immediate direct incineration or co-incineration within the same rendering site if
material is moved by a closed conveyer system.
Guidance on implementing a system for addition of GTH, approval and operation can be found
in here.
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